Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:October 2014

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

This study will assess the efficacy and safety of secukinumab in patients with active
psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,
DMARDs and / or TNFα inhibitor therapy.


Inclusion criteria:

- Male or non-pregnant, non-lactating female patients at least 18 years of age

- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6
months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of
78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

- Rheumatoid factor and anti-CCP antibodies negative

- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm
diameter or nail changes consistent with psoriasis or documented history o plaque
psoriasis

Exclusion criteria:

- Chest X-ray with evidence of ongoing infectious or malignant process

- Subjects who have previously been treated with more than 3 different TNFα inhibitors

- Subjects taking high potency opioid analgesics

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
24
sites
Boston, Massachusetts 02118
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Boston, MA
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Anniston, Alabama 36207
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Anniston, AL
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Benbrook, Texas 76126
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Benbrook, TX
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Caba, Buenos Aires
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Caba,
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Charlotte, North Carolina 28277
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Charlotte, NC
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Columbia, South Carolina 29201
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Columbia, SC
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Dallas, Texas 75216
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Eagan, Minnesota 55121
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Eagan, MN
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Freehold, New Jersey 07728
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Freehold, NJ
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Houston, Texas 77030
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Houston, TX
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Jackson, Tennessee 38305
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Jackson, TN
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Johnston, Rhode Island 02919
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Johnston, RI
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Lincoln, Nebraska 68506
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Lincoln, NE
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Mesa, Arizona 85205
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Mesa, AZ
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Mesquite, Texas 75150
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Mesquite, TX
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Newnan, Georgia 30263
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Newnan, GA
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North Charleston, South Carolina 29420
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North Charleston, SC
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Paradise Valley, Arizona 85253
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Paradise Valley, AZ
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Richmond Heights, Missouri 63117
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Richmond Heights, MO
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Seattle, Washington 98103
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Seattle, WA
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Tamarac, Florida 33321
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Tamarac, FL
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Upland, California 91786
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Upland, CA
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